Z-2827-2018Class III

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application...

Name: Z-2827-2018 Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application...
Creator: Tosoh Bioscience Inc
Published: 2018-06-05
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-06-05 / Terminated / root cause: labeling and UDI

FDA source

Tosoh Bioscience Inc began a recall of Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with... on 2018-06-05. FDA classified it as Class III and gives the reason as "Distribution of unapproved product labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2827-2018
Classification: Class III
Status: Terminated
Initiated: 2018-06-05
Posted: 2018-08-15
Terminated: 2020-04-03
Recalling firm: Tosoh Bioscience Inc
Product: Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Distribution of unapproved product labeling
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Tosoh Bioscience, notified customers via a phone call on May 29, 2018 and May 31, 2018, reference "Product Labeling-Removal". The phone call described the product, problem and actions to be taken. The firm instructed to confirm receipt of the CD containing AAMs; return the unapproved labeling; if printouts were made of any information on the CD then destroy it, if not, thank customer for response and complete the Customer Call form. The firm will provide the Customers updated CD following approval and release. Any further questions, contact Sr. QA Manager at 614-317-1909 or email: [email protected].
Quantity in commerce: 9 CDS
Distribution: US Distribution to states of: FL, MA, MT, OK, OR and WI.
Product codes and lots: rev: 6.0-040418

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2827-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2827-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-15

Product code JIX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)